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Stalevo in Early Wearing-Off Patients (SEWOP)

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Stalevo (levodopa/carbidopa/entacapone)
Levodopa/carbidopa
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Idiopathic Parkinson's disease Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day Unchanged antiparkinsonian medication for 6 weeks prior to baseline Exclusion Criteria: Secondary or atypical parkinsonism Patients with daily unpredictable OFF periods or painful dyskinesia

Sites / Locations

  • Aalborg Hospital
  • Bispebjerg Hospital
  • Århus Kommunehospital
  • South Karelia Central Hospital
  • Tampere University Hospital
  • Parkinson Klinik Bad Nauheim
  • Neurologische Klinik Bad Neustadt
  • Neurologische Klinik der Universitat Dusseldorf
  • Allgemeines Krankenhaus Harburg
  • Praxis Drs Lang, Krauss, Schreiber
  • Mater Private Hospital
  • Universitetssjukhuset MAS
  • Läkarhuset Vällingby
  • Movement Disorder Services
  • University Hospital of Wales
  • Glan Clwyd Hospital
  • Frenchay Hospital
  • Leigh Infirmary
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Stalevo (levodopa/carbidopa/entacapone)

Levodopa/carbidopa

Outcomes

Primary Outcome Measures

The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale
Clinical Global Impression of Change (investigator)
Parkinson's Disease Questionnaire (PDQ-39)
Work Impairment Questionnaire

Full Information

First Posted
July 29, 2005
Last Updated
June 19, 2009
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00125567
Brief Title
Stalevo in Early Wearing-Off Patients
Acronym
SEWOP
Official Title
Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stalevo (levodopa/carbidopa/entacapone)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Levodopa/carbidopa
Intervention Type
Drug
Intervention Name(s)
Stalevo (levodopa/carbidopa/entacapone)
Intervention Description
Oral, 50-150 mg levodopa four times daily, for up to 2 years
Intervention Type
Drug
Intervention Name(s)
Levodopa/carbidopa
Intervention Description
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
Primary Outcome Measure Information:
Title
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Time Frame
Up to 2 years of treatment
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale
Time Frame
Up to 2 years of treatment
Title
Clinical Global Impression of Change (investigator)
Time Frame
Up to 2 years of treatment
Title
Parkinson's Disease Questionnaire (PDQ-39)
Time Frame
Up to 2 years of treatment
Title
Work Impairment Questionnaire
Time Frame
Up to 2 years of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's disease Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day Unchanged antiparkinsonian medication for 6 weeks prior to baseline Exclusion Criteria: Secondary or atypical parkinsonism Patients with daily unpredictable OFF periods or painful dyskinesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Wighton, BSc (Hons)
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bhadravati SD Sastry, FRCP
Organizational Affiliation
University Hospital of Wales and Rookwood Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
DK-9000 Aalborg
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Facility Name
Århus Kommunehospital
City
Nørrebrogade 44
ZIP/Postal Code
8000
Country
Denmark
Facility Name
South Karelia Central Hospital
City
Lappeenranta
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521 Tampere
Country
Finland
Facility Name
Parkinson Klinik Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231 Bad Nauheim
Country
Germany
Facility Name
Neurologische Klinik Bad Neustadt
City
Bad Neustadt
ZIP/Postal Code
97616 Bad Neustadt
Country
Germany
Facility Name
Neurologische Klinik der Universitat Dusseldorf
City
Duesseldorf
ZIP/Postal Code
40225 Duesseldorf
Country
Germany
Facility Name
Allgemeines Krankenhaus Harburg
City
Hamburg
ZIP/Postal Code
21075 Hamburg
Country
Germany
Facility Name
Praxis Drs Lang, Krauss, Schreiber
City
Ulm
ZIP/Postal Code
89073 Ulm
Country
Germany
Facility Name
Mater Private Hospital
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
Universitetssjukhuset MAS
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Läkarhuset Vällingby
City
Vällingby
ZIP/Postal Code
SE-162 68
Country
Sweden
Facility Name
Movement Disorder Services
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0QA
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Leigh Infirmary
City
Leigh
ZIP/Postal Code
WN7 1HS
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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Stalevo in Early Wearing-Off Patients

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